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US-NJ, Global Project Statistician (VEGF - Trap) DIA7432-MZ
Job Code : DIA7432
Job Title : Global Project Statistician (VEGF - Trap)
Description : We have an immediate opportunity for a Global Project Statistician to join our Biostatistics Data Management group to support the VEGF-Trap clinical project, currently in early Phase II planning.
The VEGF-trap project is a joint venture endeavor with Regeneron Pharma. Aventis is responsible for all trial planning, execution, and submission of VEGF, a growth factor that enables blood vessel growth. The goal of the project is the suppression of VEGF within the tumors so as to prevent blood vessels from forming (i.e. thereby starving the tumor). Two indications are being explored simultaneously, namely metastatic gastric cancer and non-small cell lung cancer. Currently, the project is in early Phase II planning stages, so there is time for a new global project statistician to be introduced to the team.
Provide leadership and guidance as the statistical expert on the global project team. Optimize the chance of success of the project and minimize the development time for approvals. Accountable for all statistical aspects of project studies and submissions, including quality, thorough attention to regulatory considerations, and rigorous science.
Responsibilities:
Take a leadership role in project decision-making such as strategy for the clinical development, clinical go no-go decisions, and strategy for regulatory submissions.
Serve as the leader and provide scientific project-related directions to the biostatisticians within the project. Facilitate communication of statisticians supporting the project and pull them together as an effective team.
Review/approve project study protocols, statistical analysis plans, case report form designs, QC and validation plans, during study data review and monitoring plans, specifications for the global integrated database and study analysis datasets, clinical study reports, and submission analyses. Create "master plan" for protocols and statistical analysis plans to ensure consistency across studies.
Manage project statistical work at Aventis sites and at CROs within a matrix environment, including attention to timelines and milestones. In particular, ensure all statistical deliverables are made on-time, with quality.
Contribute to regulatory strategies and participate in negotiation including drug labeling with regulatory agencies worldwide.
Ensure the Clinical Development Plan meets global statistical and regulatory requirements for drug approval.
Provide input on data collection and validation to ensure that appropriate quality standards are met and that data can be pooled across studies.
Ensure consistency of statistical methods across studies and ensure harmonization of methods following the ICH guidelines.
Assume overall statistical responsibility for global submissions to regulatory agencies including strategy for completion of overall summaries.
Interact with regulatory agencies and prepare responses to regulatory questions.
Identify and interact with internal and external statistical experts and integrate their input into statistical strategies and approaches.
Plan for manpower and budget needs; review and monitor manpower and budget utilization. Manage and coordinate the selection and utilization of CROs.
Review publications and presentations of project study results.
Contribute to the shaping of the future of the Global Biostatistics Department.
Take additional department-wide responsibilities as by assigned by Biostatistics Head.
Requirements : Ph.D. in statistics or closely related field.
A minimum of 9 years of clinical trial experience in the pharmaceutical industry with 2-4 years experience in Oncology is required. A strong candidate with MS in statistics or closely related field and 14 years of pharmaceutical experience may also be considered.
Demonstrated strong leadership, project management, teamwork, and interpersonal skills. Excellent verbal, written and presentation skills. Proven ability to take leadership role in project team essential.
Superior understanding of statistical concepts and techniques and of clinical trial principles.
Thorough knowledge of pharmaceutical clinical development and ability to apply technical principles, theories and concepts to clinical drug development.
Understanding of the regulatory drug submissions and approval process at the regional level; experience with global submissions desirable.
Experience with corporate joint ventures desired. Experience with biologic medications is also helpful.
Proven ability to inspire and empower others.
Sought out for advice by others at senior levels.
Able to support multiple projects.
Able to work in a fully self-directed manner.
Supervisory Responsibilities:
Mentor and provide guidance to biostatisticians and other Lead Statisticians, as appropriate.
City : Bridgewater
State : New Jersey
To apply, please choose the US portion of the Aventis Recruitment Center at our website: www.aventis.com. Please create a profile with your resume and submit it to Job Code DIA7432. |
